<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220910055928N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-31</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of two methods of uriculotherapy and reflexology on the severity of labor pain and the durationof the active stage of labor</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two methods of uriculotherapy and reflexology on the severity of labor pain and the durationof the active stage of labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65803</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is done using Random Allocation software and simple randomization method, and people are examined in one of three groups. Then prepare 96 numbered envelopes that contain the treatment method code and the informed consent form, and one of the envelopes will be assigned in the order of number when people enter, Blinding description: To prevent the study analyst from knowing, each group will be assigned a code that only the researcher will know about their interpretation, and coded information will be delivered to the statistical consultant for analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>The effect of reflexology and auriculotherapy on the severity of labor pain.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: In the auriculotherapy group, after disinfecting the ear in the lobe of the ear, on the points located in the figure (1-1, 1-2, and 1-3), including the parts of the uterus, pituitary gland, pelvis, adrenal gland, endocrine gland and the point of Shan Man, spleen point and the thoracos point, pressure is applied once at 4 cm dilatation and again at 6 to 8 cm dilatation for 20 minutes each. Then the researcher will observe the mother until delivery and after that. Intervention 2: The second intervention group: gentle massage on the entire sole of the foot, and then pressure will be applied on the specified and relevant areas. These areas will include the pituitary gland, right in the center of the big toe of both feet, the solar plexus approximately four toes wide below the base of the toes of both feet and in the center. The genital area is located below the ankles of both legs and on both sides. Reflexology will be performed for 20 minutes on each leg for a total of 40 minutes starting with 4 cm dilation and entering the active phase of labor by the researcher, and again at 6 and 8 cm dilation, then the researcher until the time of delivery and after that. will monitor the mother. Intervention 3: Control group: In the control group Zao will receive only routine care.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Main implications of the study.

When:
The access period starts 6 months after the results are published.

To whom:
For researchers working in academic and scientific institutions

Conditions:
It will be used to cite the source in the articles and any other type of analysis will be done in consultation with the first author of the article

Where to obtain:
To receive the desired documents or data, please email Ms. Zainab Ameri, Master of Midwifery Counseling, working at Bahar Hospital, at ameri.z@shmu.ac.ir or call 00982332395054.

How to obtain:
To receive documents or other items after applying, they will receive a clear answer within two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zeynab Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari Street, Shahid Arab Asadi Alley</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3655119402</zip>
        <telephone>+98 23 3251 3250</telephone>
        <email>zeynabameri2014@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zeynab Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari Street, Shahid Arab Asadi Alley</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3655119402</zip>
        <telephone>+98 23 3251 3250</telephone>
        <email>zeynabameri2014@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>obtaining informed consent.
Low-risk pregnancy (not having a placenta, no polyhydramnios, reduced fetal movements, as well as IUGR
Gestation age 37-40 weeks
Singleton pregnancy
Cephalic presentation
4 cm dilation and uterine contractions for 30 seconds and 2-3 contractions in 10 minutes
Age between 18-35 years
Having at least reading and writing literacy
Having at least one healthy ear
Having at least one healthy foot (absence of cuts, burns, fungal infections, warts, warts, and any kind of numbness in the foot)
Has a safe water bag</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receiving painkillers within 3 hours before the start and during the study
Drug addiction
Using oxytocin to induce and accelerate childbirth
Emergency caesarean section for any reason before the completion of the first stage of labor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>061</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Failed induction of labour</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: In the auriculotherapy group, after disinfecting the ear in the lobe of the ear, on the points located in the figure (1-1, 1-2, and 1-3), including the parts of the uterus, pituitary gland, pelvis, adrenal gland, endocrine gland and the point of Shan Man, spleen point and the thoracos point, pressure is applied once at 4 cm dilatation and again at 6 to 8 cm dilatation for 20 minutes each. Then the researcher will observe the mother until delivery and after that.</i_keyword>
      <i_keyword>The second intervention group: gentle massage on the entire sole of the foot, and then pressure will be applied on the specified and relevant areas. These areas will include the pituitary gland, right in the center of the big toe of both feet, the solar plexus approximately four toes wide below the base of the toes of both feet and in the center. The genital area is located below the ankles of both legs and on both sides. Reflexology will be performed for 20 minutes on each leg for a total of 40 minutes starting with 4 cm dilation and entering the active phase of labor by the researcher, and again at 6 and 8 cm dilation, then the researcher until the time of delivery and after that. will monitor the mother.</i_keyword>
      <i_keyword>Control group: In the control group Zao will receive only routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: Time intervals of pain intensity measurement by visual pain scale will be done first at 4 cm dilatation and then at 6 and 8 cm dilatation. Method of measurement: The way to measure the outcome variable will be a horizontal ruler (visual scale of pain).</prim_outcome>
      <prim_outcome>The duration of the active phase of labor. Timepoint: Time intervals of pain intensity measurement by visual pain scale will be done first at 4 cm dilatation and then at 6 and 8 cm dilatation. Method of measurement: The way to measure the outcome variable will be a horizontal ruler (visual scale of pain).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-30</approval_date>
        <contact_name>Ethics Committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>Shahrood University of Medical Sciences, Heftam Tir Square, Tehran Street Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
